Over view of the program - Cumulative –or- Aggregate reporting, also known as Periodic Reporting, plays a key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports. The periodic reports plays an important role in risk-benefit evaluation of the drug and involves collective analysis of cases in the database, monitoring regulatory actions, literature searches etc. They are required to be submitted to various regulatory agencies to comply with the regulatory requirements. The advantage of aggregate reporting is that it provides a broader view of the safety profile of a drug.
Join the Workshop in Aggregate Reporting in Drug Safety and Pharmacovigilanceand upgrade your skillset today.
- Industry Relevant Curriculum
- Access to Oracle Argus Safety database
- Live Online Sessions
- Introduction to Aggregate Reports
- Extraction of NDA line listing from Argus Safety for preparation of PADERs
- Overview of PADERs and its preparation
- Extraction of ICH line listing from Argus Safety for preparation of PSURs
- Overview of PSURs and its preparation
- Literature Search and identification of Potential and Identified Risk
- Extraction of Case listing for Aggregate reporting purposes
- Live Online Sessions via WebEx
- Hands-on Practical training on the Oracle Argus safety database.
- 20 hours of Live Online Sessions via WebExand
- Hands-on training on the Oracle Argus Safety database
Tuition Fee - $ 999
At the end of this Program you will be able to learn:
- The procedure to generate line listings
- Summarize tabulation of ADR cases in Oracle Argus Safety Database
- Detailed discussion on
- Content and preparation of the reports
- Country specific requirements
- Guidelines governing periodic reports
Who should enroll?
- Life Science/Medical/Pharmacy/Nursing Graduates
- Drug Safety associates
- Drug Safety assistants
- Pharmacovigilance Associates
For more information please contact: